BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON COATED VICRYL PLUS ANTIBACTERIAL SIZE 4-0 W/

    MDR report key: 887535 · Received July 26, 2007

    Report

    Report Number
    MW5003168
    Event Type
    Injury
    Date Received
    July 26, 2007
    Date of Event
    July 24, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS A MALE WHO UNDERWENT AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. POST PROCEDURE, THE WOUND WAS BEING SUTURED BY A PHYSICIAN WHEN THE SUTURE MATERIAL SEPARATED FROM THE NEEDLE. THE SUTURE WAS A COATED VICRYL PLUS ANTIBACTERIAL SIZE 4-0 WITH CONVENTIONAL CUTTING NEEDLE PC-1 BY ETHICON, LOT# ZA6865. THE NEEDLE CAME OFF UNDER THE PT'S SKIN, AND REQUIRED FURTHER INTERVENTION. DIAGNOSIS OR REASON FOR USE: USED FOR WOUND CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON COATED VICRYL PLUS ANTIBACTERIAL SIZE 4-0 W/ ANTIBACTERIAL SUTURE GAM ETHICON, INC. ZA6865

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability COATED VICRYL PLUS ANTIBACTERIAL